Digital Quality, Csv Systems Specialist

Lonza Group

Hyderabad, India
Not specified; not specified; comprehensive benefi...
Computer systems validation (csv) experience
Kneat gx system administration
Gamp 5 and 21 cfr part 11 compliance knowledge
You will serve as the primary business administrator for the Kneat Gx platform, driving the digital transformation of validation processes

Job Summary

  • You will serve as the primary business administrator for the Kneat Gx platform, driving the digital transformation of validation processes.
  • The role requires ensuring data integrity and compliance with GxP regulations while supporting internal audits and regulatory inspections.
  • Candidates will benefit from an agile career culture with global exposure and comprehensive benefits including medical insurance.

Matching Summary

You will serve as the primary business administrator for the Kneat Gx platform, driving the digital transformation of validation processes.

Salary

Not specified; Not specified; Comprehensive benefits package including medical insurance and wellness programs

Skills & Requirements

Must-have

  • Computer Systems Validation (CSV) experience
  • Kneat Gx system administration
  • GAMP 5 and 21 CFR Part 11 compliance knowledge
  • Electronic records and signatures management
  • User access and role configuration

Nice-to-have

  • TrackWise familiarity
  • Document Management Systems (DMS) experience
  • Strong analytical skills for process optimization
  • Ability to train diverse user groups
  • Excellent English communication skills

Key Requirements

  • Degree in Life Sciences, IT, Engineering, or related field
  • Significant experience in CSV with electronic validation platforms
  • Advanced proficiency in Kneat Gx or similar e-validation software

Work Rights

Not specified

Tailored Resume

Cover Letter